Prostate Cancer Clinical Trial
A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer
Summary
Study CP-MGC018-03 is a randomized, open-label, seamless, Phase 2/3 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.
The Phase 2 stage will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg Q4W and 2.7 mg/kg Q4W) compared to the control arm (abiraterone or enzalutamide). Approximately 150 participants will be randomized 1:1:1 in Phase 2 among the three study treatment arms (two vobramitamab duocarmazine experimental arms and one control arm). An interim analysis will be performed to select the Phase 3 dose regimen for the vobramitamab duocarmazine experimental arm for Phase 3 after approximately 150 participants enrolled in Phase 2 have been followed for at least 2 months (60 days).
The Phase 3 stage will assess efficacy of the selected dose regimen for the vobramitamab duocarmazine experimental arm versus the control arm (abiraterone or enzalutamide). Approximately 270 additional participants will be randomized 1:1 between each study treatment arm in Phase 3 (one vobramitamab duocarmazine experimental arm and the control arm).
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
Participants must have ≥ 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of <60 days used as bridging to lutetium-177 is permitted.
Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
Acceptable physical condition and laboratory values.
Exclusion Criteria:
Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of <60 days used as bridging for lutetium-177 is permitted.
Received >3 total prior therapies for mCRPC
Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
Untreated, symptomatic central nervous system (CNS) metastasis.
Prior treatment with any B7-H3 targeted agent for cancer,
Contradictions to the use of corticosteroid treatment
Prior stem cell, tissue, or solid organ transplant.
Use of products that have published anti-prostate cancer activity or are known to decrease PSA.
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There are 29 Locations for this study
Fountain Valley California, 92708, United States More Info
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Los Angeles California, 90095, United States More Info
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Jacksonville Florida, 32209, United States More Info
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Orange City Florida, 32763, United States More Info
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Covington Louisiana, 70433, United States More Info
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Canton Ohio, 44718, United States More Info
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Myrtle Beach South Carolina, 29572, United States More Info
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Charlottesville Virginia, 22908, United States More Info
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Fairfax Virginia, 22031, United States More Info
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Seattle Washington, 98109, United States More Info
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Malvern Victoria, 3144, Australia More Info
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Melbourne Victoria, 3000, Australia More Info
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Charleroi Hainaut, 6000, Belgium More Info
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Libramont Luxembourg, 6800, Belgium More Info
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Godinne Namur, 5300, Belgium More Info
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Gent , 9000, Belgium More Info
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Bordeaux Gironde, 33076, France More Info
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Montpellier Herault, 34298, France More Info
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Saint-Mandé Ile De France, 94160, France More Info
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Saint-Grégoire Ille Et Vilaine, 35760, France More Info
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Florence , 50134, Italy More Info
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Gwangju , 61469, Korea, Republic of More Info
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Seoul , 03080, Korea, Republic of More Info
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Seoul , 03722, Korea, Republic of More Info
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Sabadell Barcelona, 08208, Spain More Info
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Barcelona , 08036, Spain More Info
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Barcelona , 08036, Spain More Info
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Lugo , 27002, Spain More Info
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Sutton Surrey, SM2 5, United Kingdom More Info
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Oxford , OX3 7, United Kingdom More Info
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